FDA recall D-0488-2015

Actavis Laboratories, FL, Inc. · Class III · drug

Product

Cartia XT (diltiazem HCl extended-release capsules, USP), Once-A-Day Dosage, 300 mg, 90-count bottles, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA --- NDC 62037-0600-90

Reason for recall

Presence of Foreign Substance; fine residue or dust identified as aluminum may be on exterior of the capsule shell

Distribution

Nationwide

Key facts

Status: Terminated
Initiation date: 2015-03-26
Report date: 2015-04-22
Termination date: 2016-12-30
Voluntary/Mandated: Voluntary: Firm initiated
Location: Davie, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0488-2015